Ethicon Endo-Surgery Inc recalls Curved Intraluminal Staplers, 33 mm diameter, Model CDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are ana…

Recall date

April 11, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1270-2019

FDA classification

Class I

Brand / firm

Ethicon Endo-Surgery Inc

Sold / distributed

Worldwide Distribution: US (nationwide) and countries of: Argentina, Aruba, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Ecuador, Egypt, El Salvador, Guatemala, Honduras, India, Indonesia, Israel, Jamaica, Japan, Jordan, Korea, Kuwait, Lebanon, Malaysia…

Why it was recalled

The staplers may have an insufficient firing stroke to break the washer and completely form staples.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Curved Intraluminal Staplers, 33 mm diameter, Model CDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.